It was 30 years ago that pioneering cardiologist Andreas Gruentzig performed the first balloon-angioplasty procedure on a heart patient, giving birth to a specialty that has transformed treatment of coronary-artery disease in the past two decades.

But as interventional cardiologists toast their founding father at a big conference beginning this weekend in Washington, D.C., the glass-clinking will be muted by the sober state of their business -- in particular the status of its flagship device known as the drug-eluting stent.

Johnson & Johnson reported this week that sales of its Cypher stent plunged more than 40% in the third quarter from a year earlier; revenue for Boston Scientific Corp.'s Taxus stent, Cypher's only current rival in the U.S., fell 22%, and Boston Scientific announced a restructuring that includes laying off 2,300 workers.

The devices are tiny metal sleeves implanted to prop open diseased arteries; the drug-coated version minimizes chances that the stent will reclog within a few months, a problem that has required redo procedures for about 15% to 20% of bare-metal ones.

He became the face of post-September 11 illness after his death in early 2006, galvanizing lawmakers and health care advocates to lobby for research and treatment for thousands who breathed the debris-filled air at ground zero.

James Zadroga, the 34-year-old retired police detective who died of respiratory failure after working hundreds of hours at the World Trade Center site, was often cited by those advocates as a "sentinel case" -- the first health-related casualty linked to ground zero, suggesting there would be more to follow.

The city's medical examiner stunned that community this week with a letter declaring that Zadroga's death had nothing to do with the toxic air he breathed while working at ground zero.

Rejecting another medical examiner's autopsy, New York City Chief Medical Examiner Charles Hirsch said in a letter to Zadroga's family that his death was not caused by exposure to trade center dust.

"It is our unequivocal opinion, with certainty beyond doubt, that the foreign material in your son's lungs did not get there as the result of inhaling dust at the World Trade Center or elsewhere," said the letter to Zadroga's father. It was signed by Hirsch and another medical examiner, Michele Slone. The letter was obtained Thursday by The Associated Press.

The article also notes that "[t]he city is defending itself in a lawsuit filed by thousands of workers who say they were not properly protected from the dust."

Over-the-counter cold and cough medicines don't work for children under age 6 and giving the common medicine to young children cannot be recommended, a Food and Drug Administration advisory committee said Friday.

The panel of health experts looking at how safe and effective antihistamines, decongestants, antitussins and expectorants are in children said it is not appropriate to take data from adults and apply it to children under 12.

After a two-day hearing on the safety of the medicine, the panel called for more studies about how these drugs affect children.

Although the panel's recommendation is nonbinding, it could lead to changes in how cough and cold medicine is used.

The article also notes that since 1969, there have been 54 reported deaths in children from decongestants and 69 deaths in children from antihistamines. Will the recent publicity and FDA Advisory Panel recommendation result in many lawsuits being filed for child deaths putatively from cough and cold medications? The Consumer Healthcare Products Association argues that consumer misuse of the cough-and-cold medications may be the cause of deaths, which suggests that any cases filed will turn heavily on individual product use, as well as other individual issues of medical causation.

The Supreme Court declined to review the Florida Supreme Court's decision in Engle v. Liggett Group, 945 So.2d 1246 (Fla. 2006) on October 1, 2007. The docket for the cert petition in R.J. Reynolds v. Engle can be found here. In the Engle decision the Florida Supreme Court affirmed the dismissal of a $145 million classwide punitive damages verdict, but it also allowed certain liability findings made in Phase I of the trial to stand. This means that the defendants cannot relitigate some of the issues that it lost in the trial. The defendants' argument that the question of punitives lacked sufficient commonality for class treatment was adopted, but this ruling on lack of commonality did not extend to some of the underlying issues of liability which did have the requisite commonality, according to the court. This means that former members of the class can use these findings offensively against the defendants in future suits.

Medtronic Inc.'s decision to stop selling potentially defective defibrillator leads has prompted scrutiny of the devices and of how safety concerns about them were handled by the company and the Food and Drug Administration.

Plaintiffs attorneys, a consumer group and Iowa Sen. Chuck Grassley are examining the history of the Sprint Fidelis leads, which are electrical wires that connect the hearts of patients to the defibrillators implanted in their chests.

On Monday, Minneapolis-based Medtronic disclosed that the Sprint Fidelis wires have fractured in about 2.3% of the 268,000 models made, 235,000 of which are still implanted in people. The company said the fractures may have contributed to five deaths.

In early signs of the pressure likely to come for Medtronic and the FDA, Mr. Grassley, a Republican, last night sent letters to the company and the agency asking for more information about the leads. Separately, consumer group Public Citizen argued in a letter that the company and agency should have taken action sooner.

According to the press release issued yesterday by plaintiffs' counsel Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP, this is a case of a company that failed to learn its lesson from previous litigation. The release quotes attorney Hunter Shkolnik: "I believe that this new Medtronic litigation will follow the pattern of the previous litigation. It is unfortunate that Medtronic did not learn a lesson from it and stop sales much earlier than it did. The medical community published reports about this defect and Medtronic refused to act on it."

Ted Frank at Point of Law sees it differently. He describes the recall as "undertaken in an abundance of caution despite the lack of statistically significant evidence" and notes that "Medtronic's quick disclosure and recall contrasts favorably with the slower recall by Guidant three years ago." He suggests that the budding Medtronic litigation will provide an interesting test case for members of the plaintiffs' bar who support tort liability as a deterrent: "Will Medtronic be rewarded in the courtroom, or will they face the same degree of liability and litigation expense (or worse) as that of Guidant? And if the latter, where does the supposed incentives of the modern-day product liability system come from?"

It has long been an open secret among heart doctors: Flaws in the fragile wires, or "leads," connecting cardiac electrical devices to patients' hearts are far more frequent than malfunctions in the devices themselves.

Now that Medtronic Inc. has pulled its Sprint Fidelis leads from the market due to their risk of fracturing, hundreds of thousands of heart patients have been alerted to that reality. And they must decide how to respond.

The company, which says that 235,000 patients world-wide have a Sprint Fidelis attached to their hearts, recommends that patients see their doctors immediately. A cardiologist can reprogram a patient's defibrillator to heighten its ability to sense a defect in a lead so it can send out a warning beep if a problem is detected. Some doctors are also recommending that patients sign up for Medtronic's monitoring system, known as CareLink, which could alert patients to a possible fracture in the lead.

BNA Law Week reports a new decision from the 11th Circuit holding that military contractors do not enjoy the same immunity to suit as the US Government under Feres v. United States, 340 U.S.135 (1950). The case is McMahon v. Presidential Airways, Inc., No. 06-15303 (11th Circuit, 10/5/07). The lawsuit was brought by survivors of three soldiers who died in an airplane crash in Afghanistan. The court also held that the political question doctrine does not render the case non-justiciable, but did not rule on the question of whether a "sensitive military function" protects the contractor from suit.

My prediction is that suits by soldiers and civilians against military contractors will be a new type of mass tort, similar to the human rights class actions that have increased in number. We'll be seeing a military contractor Multi District Litigation in the very near future.

A jury in Reno today lashed Wyeth with a $99 million punitive damages verdict in a three-plaintiff Prempro lawsuit in Nevada state court. The massive award was predictable given how events unfolded in the case last week. On Wednesday, the jury rendered a compensatory damages verdict totaling $134.5 million. When Judge Robert Perry learned that the jury was confused about compensatory and punitive damages, he ordered the jury to reconsider the amounts, and the jury came back with a total compensation verdict of $35 million. Today, the jury returned to consider punitive damages, and unsurprisingly hit Wyeth with essentially the same amount it had intended as punishment last week. An AP story on the Houston Chronicle website -- Punitive Damages Awarded in Wyeth Case -- reports on today's punitive damages verdict:

Jurors awarded $99 million in punitive damages Monday to three Nevada women who claimed hormone replacement drugs distributed by pharmaceutical giant Wyeth caused their breast cancer. A Wyeth attorney said the award would be appealed. ...

After lawyers for both sides gave closing arguments again on Monday, the judge instructed the five-man, two-women jury to move to the punitive stage of the trial to consider whether the company's actions were so "reprehensible" that additional damages were warranted to punish it and discourage such behavior in the future. ...

The jurors returned at 1 p.m. Monday, two hours after they began deliberations following an impassioned plea by one of the plaintiffs' lawyers to return a large enough judgment to "get the attention and hold responsible" a company with a net worth of $14.6 billion.

"In 2002, if you walked out with a degree, you could find a job in the mass tort business," Mississippi College School of Law Dean Jim Rosenblatt is quoted as saying in this article in the Jackson Clarion-Ledger. "The legal employment market is tougher now than it was five years ago. There are still good jobs, but students have to start earlier and work harder to find them." According to the article, Mississippi law school graduates are finding it increasingly difficult to get jobs, and tort litigation in particular has become less lucrative, in part because of tort reforms implemented in 2001.

Catherine Sharkey (NYU) has just posted an article on SSRN titled "The Fraud Caveat to Agency Preemption." The article, which looks very interesting and timely, can be downloaded here. Here is the abstract

The “fraud caveat” is ubiquitous in key
debates on the regulatory role of tort law: Even the most ardent
supporters of either the state-based regulatory compliance defense to
tort claims against product manufacturers, or the more powerful
wholesale federal preemption of state tort law by administrative
regulations, concede that fraud changes the equation. State
legislatures that have adopted regulatory compliance provisions
immunizing prescription drug manufacturers whose drugs were approved by
the FDA from liability for damages (either entirely or just for
punitive damages) have, without exception, included the fraud caveat.
And courts interpreting these immunity statutes echo the caveat mantra.
The fraud caveat remains an undertheorized but highly revealing and
consequential aspect of regulatory preemption debates.

In
Warner-Lambert Co. LLC v. Kent (No.06-1498), the U.S. Supreme Court is
poised to answer the question whether Buckman Co. v. Plaintiffs' Legal
Committee preempts statutory fraud exceptions to drug manufacturer
immunity statutes. The question raises a narrow doctrinal issue, but
one that hits a raw federalism nerve, with correspondingly wide
reverberations in products liability preemption jurisprudence. A
satisfactory resolution of the doctrinal issue - relying upon the FDA
to police fraud in the first instance, but enlisting private litigants
on the remedial and enforcement end - provides the seeds of a more
generalizable model of agency-court cooperation for the regulation of
nationally regulated products, such as medical devices and
pharmaceuticals. This institutional approach gives primacy to the
agency to decide, in the first instance, the extent to which state law
requirements would encroach upon its regulatory scheme, but reserves
room for private litigant enforcement of federally determined standards.